UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of drug efficacy between linaclotide and lubiprostone in constipation-predominant irritable bowel syndrome patients
Title of the study (Brief title)	A clinical trial about laxative products for constipation-predominant irritable bowel syndrome
Region	Japan

Condition
Condition	constipation-predominant irritable bowel syndrome
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To compare drug efficacy of lubiprostone and linaclotide in constipation-predominant irritable bowel syndrome patients
Basic objectives2	Others
Basic objectives -Others	To evaluate association of drug efficacy with gene polymorphisms and serum cytokines
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Reduction of GSRS scores and SF-8 scores two weeks after starting medication
Key secondary outcomes	Association of drug efficacy with gene polymorphisms and serum cytokines

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	taking lubiprostone once per day for two weeks
Interventions/Control_2	taking linaclotide once ot two times per day for two weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients diagnosed as constipation-predominant irritable bowel syndrome according to ROME 4 and who don't take lubiprostone either linaclotide
Key exclusion criteria	systemic inflammatory disease, malignancy disease, history of abdominal surgery
Target sample size	50

Research contact person
Name of lead principal investigator	Akiko Shiotani
Organization	Kawasaki Medical School
Division name	Gastroenterology
Address	577 Matsushima Kurashiki city Okayama
TEL	086-462-1111
Email	shiotani@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Akiko Shiotani
Organization	Kawasaki Medical School
Division name	Gastroenterology
Address	577 Matsushima Kurashiki city Okayama
TEL	086-462-1111
Homepage URL
Email	shiotani@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Handa clinic for Internal Medicine
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	川崎医科大学附属病院（岡山県）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 17 Day
Last modified on	2019 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032761